Identity
- Trade Name
- NeoBLUE Nova FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- neoBLUE Rollstand FDA UDI
- Model / Reference
- 019040 FDA UDI
- Description
- neoBLUE Rollstand FDA UDI
Identifiers
- Catalog Number
- 019040 FDA UDI
- Primary DI / UDI-DI
- 05713315011238 FDA UDI
- 510(k) Number
- K160745 FDA UDI
- FDA Product Code
- LBI FDA UDI
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeoBLUE Nova by Natus Medical Denmark ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K160745 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
Sources (2)
- FDA UDI a19f69ea-5bca-4b82-9e37-64525a62d4f7 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026